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Oral testosterone undecanoate therapy

a testosterone and undecanoate technology, applied in the field of oral testosterone undecanoate therapy, can solve the problem that the efficacy of testosterone levels may not provide safe and efficacious levels for another patien

Active Publication Date: 2018-11-22
LIPOCINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about a way to take oral testosterone therapy for men who need it. It involves taking a fixed daily dose of testosterone ester, like testosterone undecanoate, through the mouth. This treatment does not require any adjustment of the dose and is safe and effective with no side effects. The daily dose can be taken as a single dose or split into two or three doses per day. The therapy can be continued or discontinued based on certain biomarkers, like testosterone levels, hemoglobin levels, or PSA levels. Overall, this patent provides a convenient and effective way to treat men with testosterone deficiencies.

Problems solved by technology

A dose of a testosterone product for one patient that provides safe and efficacious testosterone levels may not provide safe and efficacious levels for another patient.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example a

[0143]

Dosage Form A1Dosage Form A2Ingredient Name% w / wmg / unit% w / wmg / unitTestosterone Undecanoate10-20105-12510-15105-125PharmaceuticallyLipophilice.g. Castor oil——48-55450-560acceptableadditives*e.g. Oleic acid80-90740-895——carrierse.g. Propylene——30-40300-375glycol monolaurateOther additives** (e.g. 0-10 0-100 0-12 0-120antioxidant, solidifier, etc)Total100 840-1050100 850-1050*Lipophilic additives used in these compositions (e.g. castor oil, oleic acid, and propylene glycol monolaurate) can be replaced with other lipophilic additives or combinations described in the above contexts. This can be applied to all other examples.**Other additives exemplified as antioxidant or solidifier in these compositions can be replaced with different other additives or combinations described in the above contexts. This can be applied to all other examples.

example b

[0144]

Dosage Form B1Dosage Form B2Dosage Form B3Ingredient Name% w / wmg / unit% w / wmg / unit% w / wmg / unitTestosterone Undecanoate13-17105-12528-32210-24518-22105-245 PharmaceuticallyLipophilicMono / di-glyceride160-65435-530————acceptableadditives*(e.g. Glycerylcarriersmonolinoleate)Mono / di-glyceride2——4-850-75——(e.g. Glyceryldistearate)Fatty acid1 (e.g.——50-60400-45045-55260-650 Oleic acid)Fatty acid2 (e.g.——2-625-40——Stearic acid)Triglyceride1 (e.g.———— 8-1245-130Borage oil)Triglyceride2 (e.g.————2-410-35 Peppermint oil)Hydrophilic additives**13-17100-1402-625-4014-1860-225(e.g. Polyoxyl 40 hydrogenatedcastor oil)OtherSolidifiers4-840-55————additives***(e.g. PEG)Antioxidant 0-0.3 0-2.5 0-0.3 0-2.5 0-0.3 0-2.5Total100680-850100720-850100500-1250*Lipophilic additives used in these compositions can be replaced with other lipophilic additives or combinations described in the above contexts. This can be applied to all other examples.*Hydrophilic additives used in these compositions (e.g. polyo...

example c

[0145]

Dosage Form C1Dosage Form C2Dosage Form C3Ingredient Name% w / wmg / unit% w / wmg / unit% w / wmg / unitTestosterone Undecanoate10-15105-12510-15105-12510-15105-125PharmaceuticallyLipophilicTriglyceride (e.g.22-28220-290————acceptableadditives*Castor oil)carriersFatty acid (e.g.——24-30230-30024-30230-300Oleic acid)Mono / di-glyceride15-18145-195————derivative (e.g.Propylene glycolmonolaurate)Mono / di-glyceride————12-15110-150(e.g. Glyceryldistearate)Monoglyceride——14-18135-180 5-10 65-110(e.g. Glycerylmonooleate)Glyceride10-15100-14510-15100-1454-642-60derivative (e.g.Oleoyl polyoxyl-6glycerides)Lipophilic0.5-1.5 5-150.5-1.5 5-150.5-1.5 5-15surfactant (e.g.Lecithin)Lipophilic1-315-301-315-301-315-30surfactant (e.g.Phytosterol)Hydrophilice.g. Polyoxyl25-35250-345 6-1275-125 6-12 75-125additives**40 hydrogenatedcastor oile.g.——18-22170-22518-22170-225Polysorbate 80e.g. D-alpha-——1-312-251-312-25tocopherolOtherControl release0.5-1.5 5-150.5-1.5 5-150.5-1.5 5-15additives***agentAntioxidant 0-0....

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PUM

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Abstract

The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.

Description

PRIORITY DATA[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 62 / 427,103, filed on Nov. 28, 2016, U.S. Provisional Application Ser. No. 62 / 428,336, filed on Nov. 30, 2016, and U.S. Provisional Application Ser. No. 62 / 442,612, filed on Jan. 5, 2017, each of which is incorporated herein by reference.BACKGROUND[0002]Most testosterone based pharmaceutical products on the market employ dose titration schemes to ensure that patients are safely (e.g., avoiding unacceptably high testosterone levels) and efficaciously treated (e.g., achieving typical eugonadal testosterone levels in hypogonadal patients). Dose titrations are typically required because different patients can absorb and metabolize testosterone based products in substantially different manners. A dose of a testosterone product for one patient that provides safe and efficacious testosterone levels may not provide safe and efficacious levels for another patient.SUMMARY OF INVENTION[0003]Disclosed...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/568A61P5/26A61K9/48
CPCA61P5/26A61K9/48A61K31/568A61K9/0053A61K9/4858A61K31/575
Inventor CHIDAMBARAM, NACHIAPPANNACHAEGARI, SATISH KUMARPATEL, MAHESH V.KIM, KILYOUNG
Owner LIPOCINE
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